Clinical outcome tracking and analysis

ABSTRACT

The described invention provides a system and method for clinical outcome tracking and analysis. The clinical outcome tracking and analysis comprises sorting, outcome tracking, quality of life metrics, toxicity to therapy and cost of care. The system and method includes receiving one or more parameters. Exemplary parameters for sorting include sex, age, ethnicity, comorbidities, tobacco use, source of insurance, medical record number, primary care physician, referring physician, hospital, approved service vendors, disease-specific clinical molecular phenotype, therapy intent, stage of therapy, biomarkers, and cost of care. A plurality of patient medical records are sorted, by a clinical outcome tracking and analysis module executed by a processor, to provide a set of patient medical records satisfying the one or more parameters. A nodal address, indicating one or more variables, is applied to the sorted set of patient medical records to determine a clinically relevant set of patient medical records as the sorted set of patient medical records satisfying the one or more variables. The clinically relevant set of patient medical records is analyzed. A communication is transmitted based on the analyzing to a user to effect treatment, to monitor performance, or to reduce at least one of treatment variability, waste or inefficiency while delivering on intended outcome.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. provisionalapplication No. 61/888,418 (filed Oct. 8, 2013), the entire contents ofwhich are incorporated by reference herein.

FIELD

The present disclosure relates to the treatment of patients having adisease, and more specifically to clinical outcome tracking andanalysis.

BACKGROUND

As the general population is living longer, medical costs associatedwith the aging population are increasing. The costs associated withdiseases, such as cancer, are typically enormous. For example, cancercosts are projected to be the highest growth area in healthcare spendingwithout a commensurate improvement in outcomes. Approximately $125billion was spent in 2010 on cancer care in the United States alone, andestimates are that approximately 15-30% of the spending can becategorized as “waste”. Conventional techniques to control costs, suchas clinical pathways and disease management, are typically ineffective,but there are no quality alternatives that currently exist in the markettoday.

SUMMARY

As advancements in technology and medicine continue to occur, thescience and clinical practice of caring for diseases (such as cancer)are rapidly evolving. Often, medical professionals (e.g., oncologists)have a difficult time keeping up with these advancements. Theseadvancements, such as next generation genetic sequencing, are typicallycomplex and may present major issues for health plans and medicalprofessionals. As a result, health plans will likely need more tools andsupport to manage their medical (e.g., oncology) business. Similarly,medical professionals (e.g., physicians) will need more decision supporttools to practice best medicine and stay in business.

As described herein, a clinical outcome tracking and analysis (COTA)module is a tool to, for example, enable medical professionals and/orother users to practice better medicine, better manage and locatespecific information associated with a disease and/or patient, and tofacilitate improved control of cost.

The parameters of clinical outcome tracking and analysis includesorting, outcome tracking, Eastern Cooperative Oncology Group (ECOG)performance status; toxicity to therapy and cost of care. In one aspect,a method and system include the COTA module that receives, from a clientdevice operated by a user, one or more parameters to sort a plurality ofdata records, and, in response to the receiving, sorts the data recordsbased on the received parameters. A nodal address, indicating one ormore variables, is applied to the sorted set of patient medical recordsto determine a clinically relevant set of patient medical records as thesorted set of patient medical records satisfying the one or morevariables. The COTA module then analyzes the clinically relevant set ofpatient medical records and communicates at least a portion of theclassified and sorted data records and the updated data records to aclient device for display.

In one embodiment, each data record includes data associated with adisease and data associated with patients currently having the diseaseor patients who previously had the disease. The COTA module can receivethe data from an electronic medical record (EMR), from a user, from amedical professional, from an expert, or from any other source.

The COTA module can enable the user to perform various analyses on oneor more of the data records. For example, the COTA module can enable acomparison of data or of tracked outcomes between patients. The COTAmodule can identify a specific patient as a candidate for a specifictreatment or drug. The COTA module can communicate an analysis tool tothe client device to facilitate analysis of, for instance, theclassified and sorted data records or to enable comparison of KaplanMeier curves. In one embodiment, the COTA module can determine, based onthe tracking, whether a specific doctor associated with a patient istreating the patient in accordance with treatment techniques of otherdoctors treating other (similar) patients.

The COTA module may also transmit an alert to the client device upon theoccurrence of a trigger. A trigger may be, for example, at diagnosis, atprogression, at dose change, at drug change, at toxicity, when trendingtowards variance from a desired outcome, and/or at a specific time.

These and other aspects and embodiments will be apparent to those ofordinary skill in the art by reference to the following detaileddescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawing figures, which are not to scale, and where like referencenumerals indicate like elements throughout the several views:

FIG. 1 illustrates a block diagram of an example of some of thepressures in the oncology market and some potential solutions;

FIG. 2 illustrates a block diagram of a server computer communicatingwith a user computer over a network to provide a clinical outcometracking and analysis (COTA) module to the user computer in accordancewith an embodiment of the present disclosure;

FIG. 3 is a block diagram illustrating several functions provided by theCOTA module in accordance with an embodiment of the present disclosure;

FIG. 4A is a block diagram illustrating use of the COTA module to sortdata associated with colon cancer patients in accordance with anembodiment of the present disclosure;

FIG. 4B is a flow diagram of the COTA module sorting data throughspecific node creation in accordance with an embodiment of the presentdisclosure;

FIG. 4C is a block diagram illustrating a directed graph for determininga string of digits representing phenotype characteristics for nodaladdressing in accordance with an embodiment of the present disclosure;

FIG. 5 is a flowchart illustrating steps performed by the COTA module inaccordance with an embodiment of the present disclosure;

FIG. 6 illustrates a flow diagram of the COTA module transmitting alertsin response to triggers in accordance with an embodiment of the presentdisclosure;

FIG. 7 is a graphical representation illustrating a mobile deviceorganizing received alerts in accordance with an embodiment of thepresent disclosure;

FIG. 8 shows a graphical representation of incidence of disease bycancer subtype in accordance with an embodiment of the presentdisclosure;

FIG. 9 is a graphical representation of a search refined by variablesinput into the COTA module in accordance with an embodiment of thepresent disclosure;

FIG. 10 shows a listing of a plurality of variables pertinent to aparticular disease in accordance with an embodiment of the presentdisclosure;

FIG. 11 shows a graphical representation including real-time KaplanMeier curves with confidence intervals for pancreatic cancers inaccordance with an embodiment of the present disclosure;

FIG. 12 is a graphical representation showing Kaplan Meier curves bydisease progression in accordance with an embodiment of the presentdisclosure;

FIG. 13 is a graphical representation of real-time benchmarking ofoutcomes between two parties in accordance with an embodiment of thepresent disclosure;

FIG. 14 is a graphical representation of a cost report in accordancewith an embodiment of the present disclosure;

FIGS. 15A and 15B are graphical representations of a treatment interfacein accordance with an embodiment of the present disclosure;

FIG. 16. is a graphical representation of an outcome screen inaccordance with an embodiment of the present disclosure;

FIG. 17 is a graphical representation of a treatment details reportscreen in accordance with an embodiment of the present disclosure;

FIG. 18 is a graphical representation of an analysis screen comparingtoxicity and cost in accordance with an embodiment of the presentdisclosure;

FIG. 19 is a graphical representation of an analysis screen comparingtherapy and quality of life in accordance with an embodiment of thepresent disclosure;

FIG. 20 is a flow diagram of feedback support provided to a medicalprofessional in accordance with an embodiment of the present disclosure;

FIGS. 21-23 display embodiments of graphical representations fordifferent diagnosis types in accordance with an embodiment of thepresent disclosure;

FIG. 24 shows a graphical representation illustrating the COTA module'sdata generation and sorting for breast oncology—breast cancer from year2008 to year 2013 histology with invasive ductal carcinoma in accordancewith an embodiment of the present disclosure;

FIG. 25 shows a graphical representation illustrating the COTA module'sdata generation and sorting for breast oncology—breast cancer from year2008 to year 2013 tumor grade and stage in accordance with an embodimentof the present disclosure;

FIG. 26 shows a graphical representation illustrating the COTA module'sdata generation and sorting for breast cancer—stage IIB from year 2008to 2013 in accordance with an embodiment of the present disclosure;

FIG. 27 shows a graphical representation illustrating overall survivaloutcomes for breast cancer patients in accordance with an embodiment ofthe present disclosure;

FIG. 28 shows a graphical representation illustrating outcomes forbreast cancer—a comparison between two parties in accordance with anembodiment of the present disclosure;

FIG. 29 depicts one example of a schematic diagram illustrating a clientdevice in accordance with an embodiment of the present disclosure; and

FIG. 30 is a block diagram illustrating an internal architecture of acomputer in accordance with an embodiment of the present disclosure.

DESCRIPTION OF EMBODIMENTS

Embodiments are now discussed in more detail referring to the drawingsthat accompany the present application. In the accompanying drawings,like and/or corresponding elements are referred to by like referencenumbers.

Various embodiments are disclosed herein; however, it is to beunderstood that the disclosed embodiments and user interfaces as shownare merely illustrative of the disclosure that can be embodied invarious forms. In addition, each of the examples given in connectionwith the various embodiments is intended to be illustrative, and notrestrictive. Further, the figures are not necessarily to scale, somefeatures may be exaggerated to show details of particular components(and any size, material and similar details shown in the figures areintended to be illustrative and not restrictive). Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a representative basis forteaching one skilled in the art to variously employ the disclosedembodiments.

The present invention is described below with reference to blockdiagrams and operational illustrations of methods and devices to selectand present media related to a specific topic. It is understood thateach block of the block diagrams or operational illustrations, andcombinations of blocks in the block diagrams or operationalillustrations, can be implemented by means of analog or digital hardwareand computer program instructions. These computer program instructionscan be provided to a processor of a general purpose computer, specialpurpose computer, ASIC, or other programmable data processing apparatus,such that the instructions, which execute via the processor of thecomputer or other programmable data processing apparatus, implements thefunctions/acts specified in the block diagrams or operational block orblocks.

In some alternate implementations, the functions/acts noted in theblocks can occur out of the order noted in the operationalillustrations. For example, two blocks shown in succession can in factbe executed substantially concurrently or the blocks can sometimes beexecuted in the reverse order, depending upon the functionality/actsinvolved. Furthermore, the embodiments of methods presented anddescribed as flowcharts in this disclosure are provided by way ofexample in order to provide a more complete understanding of thetechnology. The disclosed methods are not limited to the operations andlogical flow presented herein. Alternative embodiments are contemplatedin which the order of the various operations is altered and in whichsub-operations described as being part of a larger operation areperformed independently.

Although described with respect to cancer conditions, the describedclinical outcome therapeutic analysis can be used for any clinicalcondition (e.g., cardiovascular disease, metabolic disease (diabetes),immune mediated diseases (e.g., lupus, rheumatoid arthritis), organtransplantation; neurodegenerative disorders; pulmonary diseases,infectious diseases, hepatic disorders). A practitioner would know theparameters of each such condition.

Throughout the specification and claims, terms may have nuanced meaningssuggested or implied in context beyond an explicitly stated meaning.Likewise, the phrase “in one embodiment” as used herein does notnecessarily refer to the same embodiment and the phrase “in anotherembodiment” as used herein does not necessarily refer to a differentembodiment. It is intended, for example, that claimed subject matterinclude combinations of example embodiments in whole or in part.

In general, terminology may be understood at least in part from usage incontext. For example, terms, such as “and”, “or”, or “and/or,” as usedherein may include a variety of meanings that may depend at least inpart upon the context in which such terms are used. Typically, “or” ifused to associate a list, such as A, B, or C, is intended to mean A, B,and C, here used in the inclusive sense, as well as A, B, or C, hereused in the exclusive sense. In addition, the term “one or more” as usedherein, depending at least in part upon context, may be used to describeany feature, structure, or characteristic in a singular sense or may beused to describe combinations of features, structures or characteristicsin a plural sense. Similarly, terms, such as “a,” “an,” or “the,” again,may be understood to convey a singular usage or to convey a pluralusage, depending at least in part upon context. In addition, the term“based on” may be understood as not necessarily intended to convey anexclusive set of factors and may, instead, allow for existence ofadditional factors not necessarily expressly described, again, dependingat least in part on context.

The pharmaceutical industry has placed most of its research anddevelopment (R&D) investments into specialty compounds with oncology asthe lead category. For example, approximately 30-35% of Phase 3 pipelineis oncology. These compounds are highly targeted, specialized therapiesbased on latest scientific advances and will likely require a commercialand development model different from the one that exists today.Pharmaceutical companies' current structures are typically inefficientand likely cannot be supported by their future products.

Diagnostic companies developing new companion diagnostic tests for newgeneration therapies will need new ways to educate physicians andefficient sales and distribution channels.

The reimbursement model in the U.S. will likely change from afee-for-service model to a value-based payment model. The AffordableCare Act has accelerated certain elements of this (e.g., accountablecare organizations (ACOS) & patient centered medical home (PCMHs) modelsfor primary care) and there is payer activity towards bundling paymentswithin specialties (e.g. orthopedics). The current fee-for-servicepayment model is likely not sustainable for the government, employers,other payers, and/or for physicians. Many oncologists are also findingthe economics of a fee-for-service model unsustainable. As indicatedabove, the government is likely moving towards value-based paymentmodels.

FIG. 1 illustrates a block diagram of an example of some of thepressures in, for example, the oncology market and some potentialsolutions. Oncologists 105 face financial pressures, many cannotcontinue business with their current models, and many are looking tofind new ways of leverage. Potential oncologist solutions 110 includeaggregating and new payment models, such as bundles. Pharmaceuticalcompanies (shown as “Pharma”) 115 typically have much or all of theironcology pipeline as highly targeted therapies. Additionally, the era ofblockbuster drugs is likely over. Further, the “old-world” businessmodel may no longer fit and may be too costly. Possible pharmaceuticalsolutions 120 include patient identification and changing their businessmodel. Health plans 125 typically have an increasing need to “manage”oncology. Also, there are no credible tools or capabilities internallyto perform this management. Additionally, medical professionals such asphysicians may not buy into the health plans. Potential health plansolutions 130 include new payment models (e.g., bundles) and controllingcosts.

FIG. 2 illustrates a block diagram of a server computer 205 (alsoreferred to below as server 205) communicating with a user computer(also referred to herein as client device) 210 over network 215 toprovide a clinical outcome tracking and analysis (COTA) module 220 tothe user computer 210 in accordance with one embodiment. Server 205 maygenerate and/or serve web pages, for example, to be displayed by abrowser (not shown) of user computer 210 over network 215 such as theInternet. In one embodiment, the COTA module 220 is a web page (or ispart of a web page) and is therefore accessed by a user of the usercomputer 210 via a web browser. In another embodiment, the COTA module220 is a software application, such as a mobile “app”, that can bedownloaded to the user computer 210 from the server computer 205. In afurther embodiment the COTA module 220 provides a user interface forenabling the functionality described herein.

A computing device such as server computer 205 and user computer 210 maybe capable of sending or receiving signals, such as via a wired orwireless network, or may be capable of processing or storing signals,such as in memory as physical memory states. Devices capable ofoperating as a server may include, as examples, dedicated rack-mountedservers, desktop computers, laptop computers, set top boxes, integrateddevices combining various features, such as two or more features of theforegoing devices, or the like. Servers may vary widely in configurationor capabilities, but generally a server may include one or more centralprocessing units and memory. A server may also include one or more massstorage devices, one or more power supplies, one or more wired orwireless network interfaces, one or more input/output interfaces, or oneor more operating systems, such as Windows® Server, Mac® OS X®, Unix®,Linux®, FreeBSD®, or the like.

Server 205 may include a device that includes a configuration to providecontent via a network to another device. Server 205 may, for example,host a site, such as a social networking site, examples of which mayinclude, without limitation, Flickr®, Twitter®, Facebook®, LinkedIn®, ora personal user site (such as a blog, vlog, etc.). Server 205 may alsohost a variety of other sites, including, but not limited to, businesssites, educational sites, dictionary sites, encyclopedia sites, wikis,financial sites, government sites, etc.

Server 205 may further provide a variety of services that include, butare not limited to, web services, third-party services, audio services,video services, email services, instant messaging (IM) services, SMSservices, MMS services, FTP services, voice over IP (VOIP) services,calendaring services, photo services, or the like. Examples of contentmay include text, images, audio, video, or the like, which may beprocessed in the form of physical signals, such as electrical signals,for example, or may be stored in memory, as physical states, forexample. Examples of devices that may operate as a server includedesktop computers, multiprocessor systems, microprocessor-type orprogrammable consumer electronics, etc.

In one embodiment, the server 205 hosts or is in communication with adatabase 240. The database 240 may be stored locally or remotely fromthe server 205. In one embodiment, the COTA module 220 accesses orsearches or sorts the data stored in database 240. The COTA module 220may also retrieve information over network 215 (e.g., from theInternet). Database 240 may store patient data or other pertinentmedical information. For example, the data entered into the database orthe COTA module 220 may be from experts in their respective fields(e.g., oncologists with more than 5, 10, 15, 20, 30, etc. years ofexperience). The data can be entered into the database 240 and/or theCOTA module 220 manually or automatically.

A network may couple devices so that communications may be exchanged,such as between a server and a client device or other types of devices,including between wireless devices coupled via a wireless network, forexample. A network may also include mass storage, such as networkattached storage (NAS), a storage area network (SAN), or other forms ofcomputer or machine readable media, for example. A network may includethe Internet, one or more local area networks (LANs), one or more widearea networks (WANs), wire-line type connections, wireless typeconnections, or any combination thereof. Likewise, sub-networks, such asmay employ differing architectures or may be compliant or compatiblewith differing protocols, may interoperate within a larger network.Various types of devices may, for example, be made available to providean interoperable capability for differing architectures or protocols. Asone illustrative example, a router may provide a link between otherwiseseparate and independent LANs.

A communication link or channel may include, for example, analogtelephone lines, such as a twisted wire pair, a coaxial cable, full orfractional digital lines including T1, T2, T3, or T4 type lines,Integrated Services Digital Networks (ISDNs), Digital Subscriber Lines(DSLs), wireless links including satellite links, or other communicationlinks or channels, such as may be known to those skilled in the art.Furthermore, a computing device or other related electronic devices maybe remotely coupled to a network, such as via a telephone line or link,for example.

A wireless network may couple client devices with a network. A wirelessnetwork may employ stand-alone ad-hoc networks, mesh networks, WirelessLAN (WLAN) networks, cellular networks, or the like. A wireless networkmay further include a system of terminals, gateways, routers, or thelike coupled by wireless radio links, or the like, which may movefreely, randomly or organize themselves arbitrarily, such that networktopology may change, at times even rapidly. A wireless network mayfurther employ a plurality of network access technologies, includingLong Term Evolution (LTE), WLAN, Wireless Router (WR) mesh, or 2nd, 3rd,or 4th generation (2G, 3G, or 4G) cellular technology, or the like.Network access technologies may enable wide area coverage for devices,such as client devices with varying degrees of mobility, for example.

For example, a network may enable RF or wireless type communication viaone or more network access technologies, such as Global System forMobile communication (GSM), Universal Mobile Telecommunications System(UNITS), General Packet Radio Services (GPRS), Enhanced Data GSMEnvironment (EDGE), 3GPP Long Term Evolution (LTE), LTE Advanced,Wideband Code Division Multiple Access (WCDMA), Bluetooth, 802.11b/g/n,or the like. A wireless network may include virtually any type ofwireless communication mechanism by which signals may be communicatedbetween devices, such as a client device or a computing device, betweenor within a network, or the like.

In one embodiment and as described herein, the user computer 210 is asmartphone. In another embodiment, the user computer 210 is a tablet.The user computer 210 can also be a computer, a music player, a set-topbox, a smart TV, or any other computing device.

The COTA module 220 can establish an effective way to manage patients,resulting in better outcomes at controlled costs. In one embodiment, theCOTA module 220 is the connector or interface between third parties andmedical professionals (e.g., oncologists). In one embodiment, the COTAmodule 220 is an analytic tool that sorts cancers to the highest levelof clinical and molecular fidelity. The COTA module 220 then tracksoutcomes in real-time, such as overall survival (OS), Progression freesurvival (PFS), and cost.

Overall survival may be a trial endpoint, which is usually expressed asa period of time (survival duration), e.g., in months. Frequently, themedian is used so that the trial endpoint can be calculated once 50% ofsubjects have reached the endpoint. An example is disease free survival,which is usually used to analyze the results of the treatment for thelocalized disease which renders the patient apparently disease free,such as surgery or surgery plus adjuvant therapy. In the disease-freesurvival, the event is relapse rather than death. The people who relapseare still surviving but they are no longer considered disease-free.

Progression free survival is the length of time during and aftermedication or treatment during which the disease being treated (e.g.,cancer) does not get worse. It is sometimes used as a metric to studythe health of a person with a disease to try to determine how well a newtreatment is working.

As used herein, the term “real-time” or “real time” means withoutperceivable delay or information that is delivered immediately aftercollection or processing. These terms also include a time delayintroduced by automated processing (e.g., near real-time).

In one embodiment, the COTA module 220 can alert the user of the usercomputer 210 (e.g., medical professional) at key moments to providerelevant information. The COTA module 220 can also enable communicationand collaboration between medical professionals as well as contentpublishing (e.g., by medical professionals). In one embodiment, COTAmodule 220 can enable medical professionals to execute at-risk contracts(e.g., bundled payments) with payers.

Although the COTA module 220 is described herein with respect to cancer,the COTA module 220 can be utilized advantageously to manage any diseaseor condition.

In one embodiment, descriptive elements of COTA include sorting, outcometracking, performance status/quality of life metrics, toxicity totherapy and cost of care.

FIG. 3 is a block diagram illustrating functions 300 provided by theCOTA module 220 in accordance with one embodiment.

In one embodiment, the COTA module 220 performs COTA sorting 310, whichidentifies patients satisfying one or more parameters. Parameters mayinclude, for example, demographic parameters, e.g., sex, age, ethnicity,comorbidities, tobacco use, medical record number, source of insurance,primary care medical professional, referring medical professional,hospital, approved service vendors (e.g., pharmacy), disease specificclinical and molecular phenotype, therapy intent, stage of therapy withrespect to progression of disease, and biomarkers. The parameters may bea simple indicator (e.g., positive, negative, not accessed), anumerically based parameter (e.g., tumor size), a standards basedparameter (e.g., tumor grade), etc. The parameters may be received bythe COTA module 220 as a user selected input. Patients may be sorted 310at the time of diagnosis to the highest level of clinical and/ormolecular fidelity because each patient has different mortality,morbidity, treatments and costs. The term “highest level of clinicaland/or molecular fidelity” refers to the highest level of patientinformation available according to the latest scientific and/or medicalguidelines as accepted in its pertinent field. For example, where thereare, e.g., 10 tests available for lung cancer, results of the 10 testsrepresent the highest level of fidelity for lung cancer. The COTA module220 may sort patients with lung cancer with any combination of those 10results. The COTA module 220 may include additional scientific and/ormedical guidelines as they become accepted in its pertinent field. Inone embodiment the COTA module 220 collects all information that impactssurvival and/or prognosis and/or treatment of a patient based on thelatest scientific and/or medical guidelines.

Further, the COTA module 220 performs outcome tracking and analysis 320.The COTA module 220 tracks outcomes in real time. In one embodiment, theelement Outcome Tracking includes the parameters progression freesurvival, overall survival, performance status/quality of life metrics,incidence/severity of toxicity, (e.g., the degree to which a substanceor drug can damage an individual), death, and drug utilization (e.g.,delivered dose intensity, dose interval and duration of therapy) Othertypes of outcomes are also contemplated.

The element ECOG performance status/quality of life metrics refers to amethod by which the quality of life of the patient over time can betracked. It is part of the demographic parameter disease specificclinical molecular phenotype, i.e., the stage of a patient's health atthe start of therapy, and is within Sorting. For example, a comparisonof ECOG at start of therapy (e.g., ECOG of 3), with ECOG after therapy(e.g., ECOG of 2) reflects the effect of the therapy.

In one embodiment, exemplary parameters of the element Toxicity toTherapy are incidence and severity. In one embodiment, COTA enables atrisk financial contracting between payers and providers so the partiescan reduce variability, waste and inefficiency but yet deliver on theintended outcome.

The COTA module 220 can also transmit communications, such as alerts330, to medical professionals (e.g., physicians) (or, in anotherembodiment, to a patient's insurance company or any other entity) inreal-time at key points, such as, e.g., at diagnosis, at progression, atdose change/drug change/toxicity, and/or trending towards variance fromdesired outcome. In one embodiment, the COTA module 220 provides alertsto medical professionals that identify a specific patient for which themedical professional is searching. For example, the COTA module 220 mayprovide an alert in real time to a pharmaceutical company that islooking for specific patients to administer a specific (e.g., new) drugor drug candidate. The alert may identify a specific patient that is agood candidate for the specific drug.

FIG. 4A is a block diagram illustrating sorting data associated withcolon cancer patients in accordance with one embodiment. Althoughdescribed with respect to cancer, e.g., colon cancer, the descriptionand figure can apply to any type of cancer or, in another embodiment,any type of disease for which there is data associated with patients.

Data 410 is gathered for all cancers (or, in another embodiment, formore than one type of cancer, or, in other embodiments, for allcardiovascular diseases, pulmonary diseases, gastrointestinal diseases,neurological diseases, etc), and this data 410 is narrowed to a subset420 relating to, e.g., colon cancer. In one embodiment, the subset 420of data relating to colon cancer is then analyzed and sorted by the COTAmodule 220 to produce a sorted colon cancer data set 430. The sortedcolon cancer data set 430 can include one or more groupings, where eachgrouping includes data associated with patients having the same type ofspecific colon cancer. Thus, the COTA module 220 enables the sorting ofcancers to the highest level of fidelity.

Typically, patient information is stored in electronic medical records(EMRs). EMRs, however, often contain too much information and it istherefore difficult for a medical professional to locate specificinformation of interest from the large amount of information stored inEMRs. Further, most of the information in EMRs is not relevant to theinformation for which the medical professional is searching. UnlikeEMRs, whose goal is to capture all or most of the data associated with apatient coming into a doctor's office and the patient leaving thedoctor's office, the COTA module 220 is targeted, as the module 220enables a user to locate specific data associated with particularpatients. Accordingly, the COTA module 220 can sort the data to locatespecific, specialized information. The data that the COTA module 220receives is typically via a web page, and is discrete (e.g., typicallyprovided by a user selecting one or more choices in a drop down menu orvia one or more check boxes).

COTA classifies, sorts, and facilitates the grouping of types ofpatients based on these variables results in the designation of a uniqueCOTA nodal address (CNA), which embodies those classification variables.In one embodiment, data is ingested into the system via a human user ora technical process, e.g., an API, a layer (meaning a part of theapplication which performs a particular function) in the applicationlooks at, and assesses, the information, e.g., whether it is correct,whether it is corrupt, what information is there, what information ismissing/holes in the information, how it is formatted, spelling, etc.,corrects any problems with the information it detects to date, andassigns a COTA nodal address (CNA) to that set of information. In oneembodiment, the CNA is an address to classify like data. In oneembodiment, COTA identifies the relationship between differentcharacteristics in a grouping, which allows COTA to classify informationon any patient in the grouping. In one embodiment, the set ofinformation sitting in the database is preassigned a CNA. In oneembodiment, COTA takes a large amount of information that encompassesmany different attributes, allows the user to identify certain of theattributes as a set of characteristics, and adds an attribute(s) to theinformation to say that the information is similar to other pieces ofinformation in the database, i.e., this information is of the samekind/value as the other information. Accordingly, the nodal address is anumber that enables a user to specifically compare like patients to likepatients. This specificity allows for minimizing biological variabilityof outcome and as a consequence provides greater precision regarding theeffect of therapeutic agents on outcome.

In one embodiment, a user wants to validate personal health information(PHI) from a patient, make sure it is correct in every way, and thenassign the appropriate CNA. As used herein, personal health information(PHI) refers to any information in a medical record or designated recordset that can be used to identify an individual patient and that wascreated, used, or disclosed in the course of providing a health careservice such as diagnosis or treatment. Examples of personal identifiersin PHI include, without limitation, name, all geographical subdivisionssmaller than a state, including street address, city, county, precinct,zip code; all elements of dates (except year) for dates directly relatedto an individual, including birth date, admission date, discharge date,date of death, and all ages over 89 and all elements of date (includingyear) indicative of such age; phone numbers; fax numbers; electronicmail addresses; social security numbers, medical record numbers; healthplan beneficiary numbers; account numbers; certificate/license numbers;vehicle identifiers and serial numbers, including license plate numbers;device identifiers and serial numbers; web Universal Resource Locators(URLs); Internet Protocol (IP) address numbers; biometric identifiers,including finger and voice prints; full face photographic images and anycomparable images; and any other unique identifying number,characteristic, or code (but not the unique code assigned by theinvestigator to code the data). This PHI is input for patient A into abrowser. The PHI gets sent to a classification layer and a CAN isassigned, the CAN defining attributes of patient A's record. and theninto the database, i.e., the set of patient attributes, which fallsunder this type of CAN, is joined to the CNA. Once this is complete, thenext time a user logs into the application and accesses the database,the database will return all of patient A's information and the CNAassigned. Accordingly, the user immediately understands how thispatient's symptoms/attributes should be handled, i.e., the user gets asnapshot of how that type of patient relates to other patients whoseinformation is in the database.

FIG. 4B is a flow diagram of COTA classifying and sorting as describedabove through specific node creation in accordance with one embodimentAs shown in FIG. 4B, an expert selects the variables sex or gender 440(variable A), race 445 (variable B), . . . , and KRAS 450 (variable G).K-Ras is a protein that in humans is encoded by the KRAS gene. Theprotein product of the normal KRAS gene performs an essential functionin normal tissue signaling, and the mutation of a KRAS gene is animportant step in the development of many cancers.

The COTA module 220 analyzes the classified and sorted data 430 withrespect to these variables (e.g., variables 440, 445, 450) to generate aunique COTA node 455. The COTA module 220 may apply these nodes on theclassified and sorted data to provide more clinically relevant results.The nodes are created as a set of preselected variables which areapplied to further filter the classified and sorted data. The nodes arerepresented as nodal addresses indicating the preselected variables. Thevariables may include, e.g., diagnoses, demographics, outcomes,phenotypes, etc. A phenotype is the composite of a person's observablecharacteristics or traits, such as its morphology, development,biochemical or physiological properties, phenology, behavior, andproducts of behavior. Phenotypes result from the expression of aperson's genes as well as the influence of environmental factors and theinteractions between the two. In one embodiment, the variables of a nodeare selected by experts in the pertinent field in order to partition thedata into clinically relevant results.

The COTA node 455 is represented as a nodal address within the COTAmodule 220. In one embodiment, the nodal address is represented as alist of the variables selected (as a function of a letter representingthe variable and a number representing the selection within thevariable). For example, as shown in FIG. 4B, the node 455 includes A1-2(A represents the sex or gender variable, and 1-2 represents Female andMale patients) shown with a block around both Female and Male variablesof Sex variable A. The node 455 also includes B1-4 because the node 455includes the Race variable with all of the sub-variables selected (shownwith a box around all of the Race variables). The node 455 also includesG1, as with respect to the KRAS variable, only Mut+ is selected (boxed).Thus, node 455 has a node address of A1-2, B1-4 . . . , G1.

In another embodiment, the node address is represented as a plurality ofstrings of digits separated by periods, where each string of digitsindicates one or more variables (e.g., disease, phenotype, therapy type,progression/track, sex, etc.). For example, a first string of digits mayrepresent a particular disease, a second string of digits may representa type of the disease, a third string of digits may indicate a subtypeof the disease, and a fourth string of digits may indicate a phenotype.Thus, in this example, the first string of digits may be 01 indicatingcancer, the second string of digits may be 02 indicating breastoncology, a third string of digits may be 01 indicating breast cancer,and a fourth string of digits may be 1201 representing particularcharacteristics of a phenotype such that the nodal address is01.02.01.1201. It should be understood that the nodal address mayinclude any number of strings of digits and is not limited to fourstrings.

In one embodiment, the string of digits representing the phenotype maybe provided by representing characteristics of the phenotype as adirected graph. FIG. 4C illustratively depicts a directed graph 460showing characteristics of a phenotype to provide a string of digitsrepresenting the phenotype in accordance with one embodiment. Thedirected graph 460 includes nodes representing phenotypes and edgesrepresenting a relationship between nodes. The graph is traced startingfrom root “start” node to nodes for a selected phenotype. Each edge isassociated with a number. The string of digits representing thephenotype for the node address is provided as a combination of thenumbers. For example, the string of digits for selected phenotypecharacteristics of male and white would be represented as 11. Othertypes of combinations may also be employed. Advantageously, representingcharacteristics of the phenotype as a directed graph allows for theaddition of other nodes without changing the entire structure. Thescreen's appearance is a result of the COTA nodal addresses (CNA), andits appearance can be changed however it is desired to present theinformation.

Node 455 provides the COTA module 220 with the ability to matchresources and alerts specific to each phenotype where relevant.Resources can be information, content, link to live support, etc. Eachpatient is categorized into one or more nodal addresses. One or morenodes may also be associated with each disease. In one embodiment,resources get “tagged” with appropriate, relevant nodes. In oneembodiment, nodes are fungible over time to stay current withscientific/medical advances.

Each nodal address may be associated with one or more bundles ofpredetermined patient care services (e.g., treatment plans). Each bundlemay also be associated with one or more nodes. The services included ineach bundle may be determined by one or more medical professionals, ahospital, a group, an insurance company, etc. to optimize patient careand/or cost. In one example, a bundle may indicate a number of imagingscans, a drug or choice of drugs, a schedule of when to administer thedrugs, an operation or procedure, a number and frequency of follow upvisits, etc. The bundling of patient care services may be particularlyuseful for risk contracting. For example, each bundle corresponding to anodal address (associated with a particular disease) may have apredetermined cost allowing a user (e.g., doctor, patient, etc.) tochoose an appropriate bundle. The cost may be determined or negotiatedbased on historical data associated with that particular disease ornodal address. Advantageously, the bundling of services provides costcertainty to an insurance company and/or hospital for a particulardisease. This also reduces the cost of processing and maintainingrecords. Additionally, medical professionals will know ahead of time thepredetermined course of treatment, which provides incentives tophysicians to obtain better outcomes at lower costs.

FIG. 5 is a flowchart illustrating steps performed by the COTA module220 in accordance with one embodiment. At step 505, the COTA module 220collects data records. The data records each include data associatedwith a disease (e.g., cancer). The data records may include patent datafor patients who have or who previously had the disease. For example,the data records may include diagnoses, demographics, outcomes, costs,or other pertinent information. The data records may be collected froman electronic database (e.g., an electronic medical record), provided bya user (e.g., medical professional, expert, specialist, etc.), or fromany other source. In one embodiment, the COTA module 220 stores the datarecords in database 240.

At step 510, the COTA module 220 receives one or more parameters to sortthe data records. The one or more parameters may be received from theuser computer 210 as user selected input. The one or more parameters mayinclude, e.g., diagnoses, demographics, outcomes, costs, or any otherparameter.

At step 515, the COTA module 220 sorts the data records based on the oneor more parameters. The sorting identifies patients satisfying the oneor more parameters. Patients are sorted to the highest level of clinicaland/or molecular fidelity based on the latest scientific and/or medialguidelines accept in the pertinent field. In one embodiment, the sortingis performed in real time.

At step 520, the classified and sorted data records are filteredaccording to a nodal address. The nodal address represents variablespreselected by users to provide a set of clinically relevant patients.In one embodiment, the variables of a nodal address are selected byexperts in the field. The nodal address may be represented as aplurality of strings of digits each separated by a period. The eachstring of digits may represent one or more variables (e.g., a disease,type of disease, subtype of disease, phenotypes, or any other relevantvariable). Other representations of the nodal address are alsocontemplated.

At step 525, the data records for the clinically relevant patients areanalyzed. Analyzing the data records may include tracking (e.g., in realtime) clinical outcomes of patients associated with the disease. Theoutcomes may include, for example, delivered dose intensity, therapeuticagents received, dose, dose interval, and dose duration, incidence andseverity of toxicity, cost, progression free survival (PFS), overallsurvival (OS), response rates, etc. The COTA module 220 may compare thetracked outcomes between patients. The COTA module 220 may alsodetermine, based on the tracking, whether a specific doctor associatedwith a tracked patient is treating the patient in accordance withtreatment techniques of other doctors treating other (similar) patients.In one embodiment, the COTA module 220 determines this based on theoutcomes of many patients.

In another embodiment, analyzing the data records may include updating(e.g., in real time) at least some of the data records based on thetracked outcomes. For example, the COTA module 220 may determine thatpatient ABC had colon cancer, was prescribed and has taken medicationXYZ for two years, and is now in remission for the past 3 years. If theCOTA module 220 determines this information from the tracking of patientABC, the module 220 can update the data record associated with patientABC with this information.

In other embodiments, analyzing the data records includes performing ananalysis to determine patient survival rate, such as, e.g., by creatinga Kaplan Meier curve. A Kaplan Meier curve is a curve that shows fiveyear survival rate that can be developed, e.g., for a single doctor (ormedical professional) or for a group of doctors (or medicalprofessionals). A Kaplan Meier curve can be created for overall survivaland/or progression free survival. Other types of analyses are alsocontemplated.

To facilitate analyzing, the COTA module 220 may also include ananalysis tool to the user computer 210. This analysis tool may be a userinterface that is accessible via a web page, a tab on an existing webpage, a software application, an app, etc. The user interfaces asdepicted in the figures herein are exemplary. This analysis tool mayenable a user to compare, analyze, or further sort the data records.

At step 530, the COTA module 220 provides a communication based on theanalysis. The communication may be in the form of an alert to a user. Inone embodiment, the COTA module 220 may communicate the classified andsorted data records and/or the updated data records to the user computer210. For example, the COTA module 220 communicates a table, chart, list,link, etc. that enables the user to access the sorted or updated datarecords. In another embodiment, the COTA module 220 may transmitadvertisements with (e.g., related to) the data records to the usercomputer 210. In other embodiments, the COTA module 220 may identify aspecific patient as a candidate for a specific treatment or drug. Thisinformation may be valuable to, e.g., a pharmaceutical company, a healthplan, a managed care consortium, an insurer, etc. The COTA module 220may transmit the communication to the user computer 210 or any otherentity (e.g., via network 215).

The COTA module 220 can be used by and benefit many people,professionals, and/or companies. For example and as described above, thehighly specialized pipeline of pharmaceutical companies likely requiresa new business model for many aspects (e.g., development including Phase4 trials/post-marketing surveillance, marketing, sales, pricing, andcontracting). In one embodiment, the professionals at the pharmaceuticalcompanies can use the COTA module 220 to facilitate this new businessmodel. For example, the COTA module 220 can match the right patient tothe right drug. The COTA module 220 can enable precise patientidentification via its sorting and nodal addressing abilities. In oneembodiment, the COTA module 220 provides a matching function thatenables a user (e.g., a pharmaceutical company) to locate (e.g., in realtime) one or more patients that are or would be good candidates for aspecific drug that the pharmaceutical company has released or isdeveloping.

Further, the COTA module 220 may benefit health plans. As indicatedabove, cancer care will likely become more complex, and it will likelynot be efficient for health plans to continue with direct management. Inone embodiment, health plans outsource their cancer care to the COTAmodule 220 (similar to what health plans previously did with pharmacybenefits). This may reduce their costs, such as by reducing total costof care and providing cost offsets for them, such as by replacingpathways, decreasing expensive prior authorization infrastructure,decreasing other personnel who “manage cancer”. Additionally, provisionsin the U.S. Affordable Care Act state that 85% of premiums must go toclinical care related activities versus administrative costs. In oneembodiment, the COTA module 220 provides an analytic interface withconnections to claims data to support health plans in managing theironcologists.

In one embodiment, the COTA module 220 can benefit organizations engagedin diagnostic methods or tools. Organizations engaged in diagnosticmethods or tools, such as those involved in next generation geneticsequencing, will likely need an efficient education, marketing andsales/distribution channel. Because the COTA module 220 is able toprecisely sort and identify patients and send time based alerts tophysicians (or other medical professionals), its use may benefit suchorganizations.

FIG. 6 illustrates a flow diagram 600 of alerts provided by the COTAmodule 220 in accordance with an embodiment. In one embodiment,physicians or other medical professionals are alerted based on theirpreferences. These preferences can be set by the medicalprofessional/physician and can include, for example, triggers 610 forthe alerts and/or the technique used to provide the alert. A trigger foran alert can include, for example, at new patient diagnosis 615, anupdate to a diagnosis, real-time scheduled event, changes to groupmembership (e.g., a new gene identified which might change grouping,and/or someone leaving the group), toxicity and/or dose intensity change620, at disease progression 625, administration of a particular drug,trending towards variance from desired outcome 630, and/or prospectivetime or cycle dependent alerts 635 (e.g., side effect alerts and/ordiagnostic test reminders). The alert may include a text message 640 oran email 645 sent to the user computer 210. Other types of alerts arealso contemplated, such as, e.g., a telephone call to the user computer210, an update on a web page, a social media update, a message sentusing, e.g., Twitter®, Facebook®, or other social media site, addingcontent to a software library or web page, and/or any other message orcommunication sent to or accessed by the user computer 210. Althoughdescribed above as providing alerts, a trigger can be any action thatresults in the COTA module 220 performing any other action.

FIG. 7 is a graphical representation illustrating a mobile device 705(e.g., user computer 210) organizing alerts received by the device 705in accordance with one embodiment. As shown in FIG. 7, the COTA alertsreceived are listed by a title or subject, such as New Colon CA 710, NewRenal Cell CA 715, Dose Adjustment 720, Drug Discontinuation 725, NewProgression 730, New Breast CA 735, CHOP 3^(rd) cycle alert 740,Neutropenia risk alert 745, and Clinical trial available 750. CHOP is anabbreviated name of a combination of drugs used in chemotherapy, whichincludes cyclophosphamide (Cytoxan/Neosar), doxorubicin (or Adriamycin),vincristine (Oncovin), and prednisolone, and is used, for example, totreat non-Hodgkin lymphoma.

The COTA module 220 can provide specific disease data sets (e.g., ondemand and in real time) including, for instance, incidence of disease(e.g., by a COTA sort), progression free survival by progression status,and/or overall survival. In one embodiment, the COTA module 220 canprovide a drug utilization data set, such as data associated with a fullor partial therapy, toxicity, and/or a change in therapy.

FIG. 8 shows a graphical representation 800 of incidence of disease bycancer subtype that can be provided by the COTA module 220 in accordancewith one embodiment. Here, the COTA graph 800 is for lymphoma from years2010 to 2013. A user can utilize a graph search input section 810 tonarrow the information that is graphed. The graph search input section810 can include, for example, a selection of what to report for (e.g.,minimal diagnosis, complete diagnosis, and/or audited patient, diagnosistype, cancer site/subtype, ICD9 (International Classification ofDiseases, Ninth Revision) code, Co-Morbidity, Disease Progression,Gender, Age, Date Range, Race, Diabetes, History of Tobacco Use, Historyof Prior Chemotherapy or Radiation, etc.

FIG. 9 shows a graphical representation 900 of a sort based on variablesinput into the COTA module 220 that can be provided by the COTA module220 in accordance with one embodiment. The graphical representation 900shows a COTA graph for Hodgkin's Lymphoma from years 2010-2013 split outby male vs. female. The graphical representation 900 shows statistics910 of the different patients who had this disease that were graphed inrepresentation 900. FIG. 10 shows an exemplary listing of a plurality ofvariables 1005 pertinent to a particular disease (here, variables shownare for lymphoma) in accordance with one embodiment.

FIG. 11 shows a graphical representation 1100 including real-time KaplanMeier curves with confidence intervals for pancreatic cancers that canbe provided by the COTA module 220 in accordance with one embodiment. Asdescribed above, a Kaplan Meier curve is a curve that shows five yearsurvival rate that can be developed, e.g., for a single doctor (ormedical professional) or for a group of doctors (or medicalprofessionals). A Kaplan Meier curve can be created for overall survivaland/or progression free survival. The user indicates variables for hisgraph search in graph search input section 1110.

FIG. 12 is a graphical representation 1200 showing Kaplan Meier curvesfor disease progression that can be provided by the COTA module 220 inaccordance with one embodiment. Line 1205 is for all pancreatic cancers,and bold line 1210 is for those with first progression.

FIG. 13 is a graphical representation 1300 of real time benchmarking ofoutcomes between two parties that can be provided by the COTA module 220in accordance with one embodiment. The graph 1300 includes curve 1305for outcomes of Dr. John Doe, a physician who treats pancreatic cancer,and a curve 1310 for outcomes of the rest of the doctors who treatpancreatic cancer. FIG. 13 also includes a meter 1320 measuring whetherDr. John Doe's outcomes are tracking positively or negatively.

FIG. 14 is a graphical representation of a cost report 1400 associatedwith (e.g., provided by) the COTA module 220 in accordance with oneembodiment. The screen's appearance is a result of the COTA nodaladdresses (CNA) and its appearance can be changed however it is desiredto present the information. The cost report 1400 may be associated withthe cost tab 1220 of FIG. 12. The cost report 1400 can be used, forexample, in estimating cost(s) of treatment, capturing knowledge, and/ortransforming the knowledge into specific implementations. In oneembodiment, the COTA module 220 tracks costs of various treatments,physicians, hospitals, etc. in real time. As shown in FIG. 14, the costreport 1400 illustrates a comparison between physician and average costper revenue. Cost report 1400 may also include other comparisons, suchas, e.g., hospital contribution margin in dollars and percent, hospitalaverage revenue and cost (e.g., average revenue per patient, averagecost per patient), physician average cost per case (e.g., average costper case for each physician, weight peer average), physician averagecost per revenue (e.g., average cost of imaging, lab work, evaluationand management, pharmaceuticals, medical supplies, and other expensesfor each physician), etc.

FIGS. 15A and 15B are graphical representations of a treatment interface1500 associated with (e.g., provided by) the COTA module 220 forfacilitating the connection between outcomes and treatments, inaccordance with one embodiment. As shown in FIG. 15A, the treatmentinterface 1500 may include a list the different types of treatmentadministered to (or declined by) a patient with breast cancer, such as,e.g., surgery, antineoplastic drugs, cellular therapy, radiationtherapy, etc. Treatment may be arranged according to a diseaseprogression. For example, drugs in oncology are typically given incycles, and, in any one cycle, any number of drugs can be given. In oneembodiment, a user can select a progression (e.g., represented asprogression 0 to progression 4), with progression 0 being after firstdiagnosis, cycle, and can select drugs in or from multiple categories.

In FIG. 15B, in another embodiment, a treatment interface 1510 mayinclude treatment regimens for one or more therapies, graphicallyrepresented on treatment interface 1510 as tabs 1515. Treatmentinterface 1510 may include fields to indicate a start and end data forthe regimen, dose intensity, description of treatment, specific brandsof drugs, etc. Treatment regimens may be graphically summarized orrepresented as a listing of treatments in table 1520. Table 1520 mayinclude action icons 1505 for each treatment. The action icons 1505 mayfacilitate actions, such as, e.g., editing, closing, viewing components,etc. In one embodiment, the action icons 1505 may be shortcuts toperform complex tasks (e.g., requiring multiple clicks or selections)with a single selection. For example, an icon on the diagnosis line canbring the user to the diagnosis screen.

FIG. 16 is a graphical representation of an outcome screen 1600 forfacilitating outcome tracking in accordance with one embodiment. Outcomescreen 1600 may facilitate outcome tracking from, for example, diagnosis(i.e., progression zero), first progression, second progression throughfourth progression, with each progression considered a differentdisease. The outcome screen tab can include (e.g., in one or more dropdown menus or other fields) a diagnosis date, a treatment start and enddate, a response to treatment (e.g., complete, partial, stable) and dateof response, input fields for notes on the response (e.g., the partialfield, CR-RA-Pet Negative field, the CR field, etc.), and a track enddata, which may include fields for last contact and death. The outcomescreen 1600 may also include other fields, such as, e.g., toxicity of adrug treatment, an input area enabling the input of what happened (e.g.,discontinued, continued, no change, drug dosage change, and how manytimes), number of delays, number changes in drug, and/or number reduced.In one embodiment, a user of the COTA module 220 can flag a patient.

FIG. 17 is a graphical representation of a treatment details reportscreen 1700 illustrating a comparison between cost and outcome inaccordance with one embodiment. The treatment details report screen 1700correlates cost of care to clinical outcome to optimize value of care.Cost and financial data may be collected and analyzed by hospital, bydoctor, etc. over a given time period (e.g., 5 years). The cost andfinancial data may be represented in one or more ranges of cost. In oneembodiment, the ranges of cost include range 1705 for cost greater than$25,000, range 1710 for cost from $10,000 to $25,000, and range 1715 forcost less than $10,000. When combined with clinical data, the COTAmodule 220 may provide cost data for different treatments for a giventime period based on different clinical sorts.

FIG. 18 is a graphical representation of an analysis screen 1800provided by the COTA module 220 illustrating a comparison betweentoxicity and cost in accordance with one embodiment. The screen'sappearance is a result of the COTA nodal addresses (CNA) and itsappearance can be changed however it is desired to present theinformation. The analysis screen 1800 correlates incidence and severityof toxicity to cost of care and outcomes of care. The toxicity may berepresented numerically (e.g., in ranges), by standards (e.g., grades),etc. For example, as shown in FIG. 18, toxicity is represented astoxicity grades 1-4 based on the Common Terminology Criteria for AdverseEvents (CTCAE) classification. The grade of toxicity is graphicallycompared with cost. The analysis screen 1800 may be used to optimizevalue and efficacy of care, where value is efficacy/cost. In oneembodiment, the COTA module 220 attempts to obtain high efficacy and lowcost.

FIG. 19 is a graphical representation of an analysis screen 1900provided by the COTA module 220 illustrating a comparison betweentherapy and quality of life in accordance with one embodiment. Thetherapy may be represented by treatment drugs in analysis screen 1900.However, other forms of therapy are also contemplated, such as, e.g.,surgery, procedures, etc. In one embodiment, the therapy includes anincidence, severity, and toxicity of therapy. Quality of life may bemeasured based on the average ECOG (Eastern Cooperative Oncology Group)scale, ranging from Grade 0 (i.e., fully active) to Grade 5 (i.e.,dead). Quality of life may also be measured using any suitable metric.Analysis screen 1900 may facilitate assessment of how a patient'sdisease is progressing, how the disease affects the daily livingabilities of the patient, and appropriate treatments and prognoses.

FIG. 20 is a flow diagram 2000 illustrating the alert system provided toa medical professional in accordance with one embodiment. The screen'sappearance is a result of the COTA nodal addresses (CNA) and itsappearance can be changed however it is desired to present theinformation. In one embodiment, the information in the alert is helpingthe user to make a decision in the future. In one embodiment, theinformation in the alert is providing a set of attributes that happenedin the past time period. In one embodiment, it is both proactivelyinfluencing decisions of the user and reactively providing a digestreport of how the medical personnel/Doctor did in the past week, month,quarter, etc. In one embodiment, there are different alerts fordifferent users, each of which can influence decisions that the usermakes. The alert may be employed for real time course correction todrive best value, such as, e.g., where an administered therapy deviatesfrom a desired outcome. In block 2005, definitions are triggered basedon clinical data. The definitions may be triggered using any criteria,such as, e.g., new disease diagnosis, disease progression, patientresponse, change in patient characteristics, dose change/drug toxicitychange, trend towards variance from a desire outcome, etc. The criteriamay be adjusted based on the disease and its parameters. Based on thetriggered definitions, alerts 2010-A, 2010-B, 2010-C (collectivelyreferred to as alerts 2010) are transmitted. It should be understoodthat alerts 2010 may include any number of alerts. The alerts 2010 mayinclude content or a link to content. The alerts 2010 may be transmittedto the responsible physician, other medical professionals, hospital,pharmaceutical company, or any other person or entity.

Content 2015-A, 2015-B, 2015-C (collectively referred to as content2015) is displayed, e.g., using user computer 210 to provide the alert.The content 2015 may include the patient data associated with the alert2010, a comparison, or any other relevant content. In one embodiment,the comparison may be, e.g., between physicians, between one physician'spatients and the whole patient population, between one physician and allphysicians at a particular location, etc. The comparison may be based ona trending analysis to show where treatment is trending and if it isgoing off course (i.e., results are not as good as the standard). Thecomparison may be graphically displayed as one or more curves on agraph. In one embodiment, the COTA module 220 is utilized withcloud-based computing. The COTA module 220 can also enable or utilizeconnectivity to hospital records.

In one embodiment, the content 2015 may include feedback support to themedical professional having traffic light feedback indicators (notshown) on a display. For example, blue may mean very good performance(i.e., better than standard), green may mean standard performance,yellow may mean sufficient performance but may need to pay attention,red may mean the user may need to pay attention to something regardingthe medical professional's approach to this disease. Otherimplementations of feedback indicators may also be employed.

FIGS. 21-24 show graphical representations for different diagnosis typesin accordance with one or more embodiments. FIG. 21 shows a diagnosisscreen 2100 for gastrointestinal oncology (e.g., colon cancer). FIG. 22shows a diagnosis screen 2200 for breast oncology (e.g., breast cancer).FIG. 23 shows a diagnosis screen 2300 for thoracic oncology (e.g., lungcancer). Diagnosis screens 2100, 2200, 2300 include a number ofdifferent parameters, such as tests or aspects of the disease. Theparameters may be represented as simple indicators, numerically basedparameters, standards based parameters, etc.

FIG. 24 shows a graphical representation of a reporting screen 2400illustrating the COTA module 220's data generation and sorting forbreast oncology. Reporting screen 2400 shows breast cancer from year2008 to year 2013 by histology, i.e., with invasive ductal carcinoma, inaccordance with one embodiment. The reporting screen 2400 permitsselection of breast cancer patients based on stage, age, progression, orany other parameter in real time. Advantageously, reporting screen 2400allows categorization in a clinically relevant way.

FIG. 25 shows a graphical representation of a reporting screen 2500illustrating the COTA module 220's data generation and sorting forbreast oncology. Reporting screen 2500 shows all grade 2 breast cancerfrom year 2008 to year 2013 tumor by stage, in accordance with oneembodiment.

FIG. 26 shows a graphical representation of a reporting screen 2600illustrating the COTA module 220's data generation and sorting forbreast cancer. Reporting screen 2600 shows all stage IIB breast cancersfrom year 2008 to 2013, in accordance with one embodiment. Graph 2605 onreporting screen 2600 shows all stage IIB breast cancers by progesteronereceptor status.

FIG. 27 shows a graphical representation of an analysis screen 2700illustrating overall survival outcomes for breast cancer patients inaccordance with one embodiment. FIG. 28 shows a graphical representation2800 illustrating survival outcomes for breast cancer as a comparisonbetween Dr. John Doe (bold line) and the aggregate (non-bold line)parties, in accordance with one embodiment.

In one embodiment, the “node” described above represents every possiblepermutation of the variables shown in one or more of the graphicalrepresentations (e.g., in one or more of FIGS. 21-27).

As shown in the example of FIG. 29, client device 2905 may include oneor more processing units (also referred to herein as CPUs) 2922, whichinterface with at least one computer bus 2925. Client device 2905 maybe, for example, user computer 210. A memory 2930 can be persistentstorage and interfaces with the computer bus 2925. The memory 2930includes RAM 2932 and ROM 2934. ROM 2934 includes a BIOS 2940. Memory2930 interfaces with computer bus 2925 so as to provide informationstored in memory 2930 to CPU 2922 during execution of software programssuch as an operating system 2941, application programs 2942, devicedrivers, and software modules 2943, 2945 that comprise program code,and/or computer-executable process steps, incorporating functionalitydescribed herein, e.g., one or more of process flows described herein.CPU 2922 first loads computer-executable process steps from storage,e.g., memory 2932, data storage medium/media 2944, removable mediadrive, and/or other storage device. CPU 2922 can then execute the storedprocess steps in order to execute the loaded computer-executable processsteps. Stored data, e.g., data stored by a storage device, can beaccessed by CPU 2922 during the execution of computer-executable processsteps.

Persistent storage medium/media 2944 is a computer readable storagemedium(s) that can be used to store software and data, e.g., anoperating system and one or more application programs. Persistentstorage medium/media 2944 can also be used to store device drivers, suchas one or more of a digital camera driver, monitor driver, printerdriver, scanner driver, or other device drivers, web pages, contentfiles, playlists and other files. Persistent storage medium/media 2206can further include program modules and data files used to implement oneor more embodiments of the present disclosure.

For the purposes of this disclosure a computer readable medium storescomputer data, which data can include computer program code that isexecutable by a computer, in machine readable form. By way of example,and not limitation, a computer readable medium may comprise computerreadable storage media, for tangible or fixed storage of data, orcommunication media for transient interpretation of code-containingsignals. Computer readable storage media, as used herein, refers tophysical or tangible storage (as opposed to signals) and includeswithout limitation volatile and non-volatile, removable andnon-removable media implemented in any method or technology for thetangible storage of information such as computer-readable instructions,data structures, program modules or other data. Computer readablestorage media includes, but is not limited to, RAM, ROM, EPROM, EEPROM,flash memory or other solid state memory technology, CD-ROM, DVD, orother optical storage, magnetic cassettes, magnetic tape, magnetic diskstorage or other magnetic storage devices, or any other physical ormaterial medium which can be used to tangibly store the desiredinformation or data or instructions and which can be accessed by acomputer or processor.

Client device 2905 can also include one or more of a power supply 2926,network interface 2950, audio interface 2952, a display 2954 (e.g., amonitor or screen), keypad 2956, illuminator 2958, I/O interface 2960, ahaptic interface 2962, a GPS 2964, a microphone 2966, a video camera,TV/radio tuner, audio/video capture card, sound card, analog audio inputwith A/D converter, modem, digital media input (HDMI, optical link),digital I/O ports (RS232, USB, FireWire, Thunderbolt), expansion slots(PCMCIA, ExpressCard, PCI, PCIe).

For the purposes of this disclosure a module is a software, hardware, orfirmware (or combinations thereof) system, process or functionality, orcomponent thereof, that performs or facilitates the processes, features,and/or functions described herein (with or without human interaction oraugmentation). A module can include sub-modules. Software components ofa module may be stored on a computer readable medium. Modules may beintegral to one or more servers, or be loaded and executed by one ormore servers. One or more modules may be grouped into an engine or anapplication.

FIG. 30 is a block diagram illustrating an internal architecture of anexample of a computer, such as server computer 205 and/or user computer210, in accordance with one or more embodiments of the presentdisclosure. A computer as referred to herein refers to any device with aprocessor capable of executing logic or coded instructions, and could bea server, personal computer, set top box, tablet, smart phone, padcomputer or media device, to name a few such devices. As shown in theexample of FIG. 30, internal architecture 3000 includes one or moreprocessing units (also referred to herein as CPUs) 3012, which interfacewith at least one computer bus 3002. Also interfacing with computer bus3002 are persistent storage medium/media 3006, network interface 3014,memory 3004, e.g., random access memory (RAM), run-time transientmemory, read only memory (ROM), etc., media disk drive interface 2308 asan interface for a drive that can read and/or write to media includingremovable media such as floppy, CD-ROM, DVD, etc. media, displayinterface 3010 as interface for a monitor or other display device,keyboard interface 3016 as interface for a keyboard, pointing deviceinterface 3018 as an interface for a mouse or other pointing device, andmiscellaneous other interfaces not shown individually, such as paralleland serial port interfaces, a universal serial bus (USB) interface, andthe like.

Memory 3004 interfaces with computer bus 3002 so as to provideinformation stored in memory 3004 to CPU 3012 during execution ofsoftware programs such as an operating system, application programs,device drivers, and software modules that comprise program code, and/orcomputer-executable process steps, incorporating functionality describedherein, e.g., one or more of process flows described herein. CPU 3012first loads computer-executable process steps from storage, e.g., memory3004, storage medium/media 3006, removable media drive, and/or otherstorage device. CPU 3012 can then execute the stored process steps inorder to execute the loaded computer-executable process steps. Storeddata, e.g., data stored by a storage device, can be accessed by CPU 3012during the execution of computer-executable process steps.

As described above, persistent storage medium/media 3006 is a computerreadable storage medium(s) that can be used to store software and data,e.g., an operating system and one or more application programs.Persistent storage medium/media 3006 can also be used to store devicedrivers, such as one or more of a digital camera driver, monitor driver,printer driver, scanner driver, or other device drivers, web pages,content files, playlists and other files. Persistent storagemedium/media 3006 can further include program modules and data filesused to implement one or more embodiments of the present disclosure.

Internal architecture 3000 of the computer can include (as statedabove), a microphone, video camera, TV/radio tuner, audio/video capturecard, sound card, analog audio input with A/D converter, modem, digitalmedia input (HDMI, optical link), digital I/O ports (RS232, USB,FireWire, Thunderbolt), and/or expansion slots (PCMCIA, ExpressCard,PCI, PCIe).

Those skilled in the art will recognize that the methods and systems ofthe present disclosure may be implemented in many manners and as suchare not to be limited by the foregoing exemplary embodiments andexamples. In other words, functional elements being performed by singleor multiple components, in various combinations of hardware and softwareor firmware, and individual functions, may be distributed among softwareapplications at either the user computing device or server or both. Inthis regard, any number of the features of the different embodimentsdescribed herein may be combined into single or multiple embodiments,and alternate embodiments having fewer than, or more than, all of thefeatures described herein are possible. Functionality may also be, inwhole or in part, distributed among multiple components, in manners nowknown or to become known. Thus, myriad software/hardware/firmwarecombinations are possible in achieving the functions, features,interfaces and preferences described herein. Moreover, the scope of thepresent disclosure covers conventionally known manners for carrying outthe described features and functions and interfaces, as well as thosevariations and modifications that may be made to the hardware orsoftware or firmware components described herein as would be understoodby those skilled in the art now and hereafter.

While the system and method have been described in terms of one or moreembodiments, it is to be understood that the disclosure need not belimited to the disclosed embodiments. It is intended to cover variousmodifications and similar arrangements included within the spirit andscope of the claims, the scope of which should be accorded the broadestinterpretation so as to encompass all such modifications and similarstructures. The present disclosure includes any and all embodiments ofthe following claims.

What is claimed is:
 1. A method for clinical outcome tracking and analysis, comprising: receiving one or more parameters; sorting a plurality of patient medical records to provide a sorted set of patient medical records satisfying the one or more parameters; applying a nodal address, indicating one or more variables, to the sorted set of patient medical records to determine a clinically relevant set of patient medical records as the sorted set of patient medical records satisfying the one or more variables; analyzing the clinically relevant set of patient medical records; and transmitting a communication based on the analyzing, wherein the transmitting is to a user to effect treatment, to monitor performance, or to reduce at least one of treatment variability, waste or inefficiency while delivering on intended clinical outcome.
 2. The method as recited in claim 1, wherein the clinical outcome tracking and analysis comprises sorting, outcome tracking, quality of life metrics, toxicity to therapy and cost of care.
 3. The method as recited in claim 2, wherein the parameters for sorting comprise sex, age, ethnicity, comorbidities, tobacco use, source of insurance, medical record number, primary care physician, referring physician, hospital, approved service vendors, disease-specific clinical molecular phenotype, therapy intent, stage of therapy, biomarkers, and cost of care.
 4. The method as recited in claim 1, wherein the nodal address is represented as a plurality of strings of digits, each of the plurality of strings of digits representing one of the one or more variables.
 5. The method as recited in claim 4, wherein the one or more variables include the disease-specific clinical molecular phenotype and a string of digits representing the phenotype is determined based on a directed graph.
 6. The method as recited in claim 1, wherein the nodal address is associated with one or more bundles of predetermined patient care services for treatment of the disease.
 7. The method as recited in claim 1, wherein analyzing comprises: tracking clinical outcomes of one or more patients associated with a disease; and updating records of the one or more patients with the clinical outcomes of the one or more patients.
 8. The method as recited in claim 7, wherein the clinical outcomes comprise at least one of survival, response metrics, quality of life metrics, incidence of drug toxicity, severity of drug toxicity, delivered dose intensity, drugs received, drug interval, drug duration, cost of care, and death.
 9. The method as recited in claim 1, wherein analyzing comprises: comparing tracked clinical outcomes between patients in the set of patient medical records.
 10. The method as recited in claim 1, wherein analyzing comprises: identifying a specific patient as a candidate for a specific drug.
 11. The method as recited in claim 1, wherein analyzing comprises: comparing clinical outcomes between patients based on treatment, cost, or a combination thereof in the set of patient medical records.
 12. The method as recited in claim 1, wherein analyzing comprises: comparing a therapy to a quality of life.
 13. The method as recited in claim 1, wherein transmitting a communication comprises: sending at least a portion of the analyzed set of patient medical records to a client device for display.
 14. The method as recited in claim 1, wherein transmitting a communication comprises: transmitting, in response to a trigger, an alert to a client device, the trigger comprising at least one of diagnosis, progression, dose change, drug change, toxicity, trending towards variance from a desired outcome, and a specific time.
 15. The method as recited in claim 1, wherein analyzing comprises: comparing outcome performance of a medical professional treating a disease to outcome performance of an aggregate of medical professionals treating the disease.
 16. The method as recited in claim 1, wherein the method minimizes biological variability of clinical outcome.
 17. An apparatus for clinical outcome tracking and analysis comprising: a processor; and a memory to store computer program instructions, the computer program instructions when executed on the processor cause the processor to perform operations comprising: receiving one or more parameters; sorting a plurality of patient medical records to provide a set of patient medical records satisfying the one or more parameters; applying a nodal address, indicating one or more variables, to the sorted set of patient medical records to determine a clinically relevant set of patient medical records as the sorted set of patient medical records satisfying the one or more variables; analyzing the clinically relevant set of patient medical records; and transmitting a communication based on the analyzing, wherein the transmitting is to a user to effect treatment, to monitor performance, or to reduce at least one of treatment variability, waste or inefficiency while delivering on intended outcome.
 18. The apparatus as recited in claim 17, wherein the clinical outcome tracking and analysis comprises sorting, outcome tracking, quality of life metrics, toxicity to therapy and cost of care.
 19. The apparatus as recited in claim 17, wherein the parameters for sorting comprise sex, age, ethnicity, comorbidities, tobacco use, source of insurance, medical record number, primary care physician, referring physician, hospital, approved service vendors, disease-specific clinical molecular phenotype, therapy intent, stage of therapy, biomarkers and cost of care.
 20. The apparatus as recited in claim 17, wherein the nodal address is represented as a plurality of strings of digits, each of the plurality of strings of digits representing one of the one or more variables.
 21. The apparatus as recited in claim 20, wherein the one or more variables include the disease-specific clinical molecular phenotype and a string of digits representing the phenotype is determined based on a directed graph.
 22. The apparatus as recited in claim 17, wherein the nodal address is associated with one or more bundles of predetermined patient care services for treatment of the disease.
 23. A computer readable medium storing computer program instructions for clinical outcome tracking and analysis which, when executed on a processor, cause the processor to perform operations comprising: receiving one or more parameters; sorting a plurality of patient medical records to provide a set of patient medical records satisfying the one or more parameters; applying a nodal address, indicating one or more variables, to the sorted set of patient medical records to determine a clinically relevant set of patient medical records as the sorted set of patient medical records satisfying the one or more variables; analyzing the clinically relevant set of patient medical records; and transmitting a communication based on the analyzing, wherein the transmitting is to a user to effect treatment, to monitor performance, or to reduce at least one of treatment variability, waste or inefficiency while delivering on intended outcome.
 24. The computer readable medium as recited in claim 23, wherein the clinical outcome tracking and analysis comprises sorting, outcome tracking, quality of life metrics, toxicity to therapy and cost of care.
 25. The computer readable medium as recited in claim 23, wherein the parameters comprise sex, age, ethnicity, comorbidities, tobacco use, source of insurance, medical record number, primary care physician, referring physician, hospital, approved service vendors, disease-specific clinical molecular phenotype, therapy intent, stage of therapy, biomarkers and cost of care.
 26. The computer readable medium as recited in claim 23, wherein analyzing comprises: tracking clinical outcomes of one or more patients associated with a disease; and updating records of the one or more patients with the clinical outcomes.
 27. The computer readable medium as recited in claim 23, wherein the clinical outcomes comprise at least one of survival, response metrics, quality of life metrics, incidence of drug toxicity, severity of drug toxicity, delivered dose intensity, drugs received, drug interval, drug duration, cost of care, and death.
 28. The computer readable medium as recited in claim 23, wherein analyzing comprises: comparing clinical outcomes between patients based on treatment, cost, or a combination thereof in the set of patient medical records.
 29. The computer readable medium as recited in claim 23, wherein analyzing comprises: comparing tracked clinical outcomes between patients in the set of patient medical records.
 30. The computer readable medium as recited in claim 23, wherein analyzing comprises: identifying a specific patient as a candidate for a specific drug.
 31. The computer readable medium as recited in claim 23, wherein analyzing comprises: comparing clinical outcome between patients based on treatment, cost, or a combination thereof in the set of patient medical records.
 32. The computer readable medium as recited in claim 23, wherein analyzing comprises: comparing a therapy to a quality of life.
 33. The computer readable medium as recited in claim 23, wherein transmitting a communication comprises: sending at least a portion of the analyzed set of patient medical records to a client device for display.
 34. The computer readable medium as recited in claim 23, wherein transmitting a communication comprises: transmitting, in response to a trigger, an alert to a client device, the trigger comprising at least one of diagnosis, progression, dose change, drug change, toxicity, trending towards variance from a desired outcome, and a specific time. 